BioPharma Dive2d
FDA approves drugs from Vertex, Novo, Bristol Myers to wrap 2024
The agency’s main drug review office cleared 50 novel medicines last year, short of 2018’s record total but on the higher end ...
clinicaladvisor.com2d
FDA Approval Increases Eligibility for Cystic Fibrosis Medication Trikafta
According to Vertex Pharmaceuticals, approximately 300 additional people with CF are now eligible to receive treatment.
Pharmaceutical Technology5d
Navocaftor by Sionna Therapeutics for Cystic Fibrosis: Likelihood of Approval
Navocaftor is under clinical development by Sionna Therapeutics and currently in Phase II for Cystic Fibrosis.
Pharmaceutical Technology5d
SION-2851 by Sionna Therapeutics for Cystic Fibrosis: Likelihood of Approval
SION-2851 is under development for the treatment of cystic fibrosis. It is a small molecule administered orally. It is a first generation corrector. The drug candidate targets cystic fibrosis ...
Vertex Secures FDA Approval for New Cystic Fibrosis Drug Alyftrek
The FDA's nod is based on late-stage data, which show that treatment with VRTX's Alyftrek enhances patient benefit compared ...
FiercePharma12d
Vertex snags FDA nod for once-daily cystic fibrosis triplet Alyftrek as switch from Trikafta kicks off
As Vertex Pharmaceuticals reels from a painful trial readout for its pain candidate suzetrigine, the Boston biotech has ...
Vertex secures two FDA wins for cystic fibrosis, both with boxed warnings
Vertex has won two cystic fibrosis approvals from the FDA, but the agency included high-level safety warnings.
The Pharma Letter12d
Vertex nabs FDA approval for Alyftrek and Trikafta
US drugmaker Vertex Pharmaceuticals’ shares were unmoved on Friday, despite receiving two new regulatory authorizations.
Vertex's Cystic Fibrosis Drug Alyftrek Gets FDA Approval
(RTTNews) - Vertex Pharmaceuticals Inc. (VRTX) Friday announced that the U.S. Food and Drug Administration (FDA) has approved Alyftrek for treatment of cystic fibrosis.
MarketWatch15d
Vertex Gains FDA Approval for Cystic Fibrosis Drug Alyftrek
It is the first once-daily treatment for cystic fibrosis transmembrane conductance regulator (CFTR) modulator, Vertex said. Alyftrek is Vertex's fifth CFTR modulator to secure FDA approval.
Investing15d
FDA expands approval for cystic fibrosis drug Trikafta
TRIKAFTA, a combination of elexacaftor, tezacaftor, and ivacaftor, is designed to enhance the function of the defective protein caused by cystic fibrosis transmembrane conductance regulator (CFTR) ...